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Multinational pharma giant booked in connection with steroids

Four officials of multinational pharma giant Boehringer Ingelheim have been booked in connection with steroids found in horse food.

The state food and drug administration has accused the officials of the 125-year-old German company of violating the Drugs and Cosmetics Act.

The FDA has said in its inquiry report that horse food supplements manufactured by Boehringer Ingelheim in its Denmark factories, which was given to Royal Western India Turf Club (RWITC) horses at the Mahalaxmi racecourse, contained Boldenone, a banned anabolic steroid.

Dr Jochen Gann, Germany-based director, Sharad Tyagi, MD of the Indian subsidiary, Dr Sandeep Juneja, director of animal health and Dr Vaishali Salunkhe, assistant manager, under multiple sections of DCA. If found guilty, the officials can be jailed for 3-5 years and fined Rs1,00,000.

Equitop Gonex Nutritional Supplement, Equitop Myoplast Pearl Granules and Equitop Pronutrin fed to RWITC race horses were not of standard quality. The supplements contained up to 2.42 microgram per kilo banned drug Boldenone without mentioning it in the labels.

"Samples of the supplements seized from stables at the race course and from a wholesaler in Navi Mumbai show the presence of Boldenone. But it is not there in the list of ingredients," a senior FDA official said. "Using drugs in food supplements require import licences. They company doesn't have relevant licences and has also violated labelling requirements by withholding information about Boldenone."

The FDA inquiry revealed that Boehringer Ingelheim India Pvt Ltd in Bandra (East), a subsidiary of the parent company, imported the supplements from Germany. It was later marketed and sold to RWITC in Mumbai through Hari Om Pharma, a wholesaler in Navi Mumbai's Koperkhairne. The FDA concluded that stock worth Rs22,56,000 lying in the Navi Mumbai godowns was contaminated with Boldenone

Boehringer Ingelheim has retorted by filing two writ petitions in the Bombay high court pleading for the FDA case to be quashed. The matter will come up for hearing on February 21. "Products in question are not drugs but animal food supplement. Drugs and Cosmetics Act is not applicable because the product is labelled 'not for medicinal use'," according to its petition.

But FDA has said in its report that the labelling of ingredients is misleading. The label on a 1.5kg jar of Equitop Gonex Nutritional Supplement (costs Rs4,200) says it contains dried shell fish extract, rich in polysaturated fatty acids and glycogen, and supplies "important nutrients that are channelled to areas where they are most needed".

What is Boldenone?
The Boldenone controversy started in 2010 after the urine samples of three RWITC tested positive for the drug Boldenone is a veterinary steroid hormone derived from testosterone
It is banned but used illicitly by bodybuilders and atheletes. Also administered to race horses
In a horse, Boldenone stimulates appetite, causes weight gain, increases lean muscle mass, and makes it hyper-aggressive